Status:
COMPLETED
Effectiveness and Safety of Tofacitinib in Patients With Recalcitrant Frontal Fibrosing Alopecia : A Pilot Study
Lead Sponsor:
Institute of Dermatology, Thailand
Conditions:
Frontal Fibrosing Alopecia
Lichen Planopilaris of Scalp
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study aims to determine the efficacy and safety of tofacitinib therapy in Thai patients with recalcitrant frontal fibrosing alopecia. The main questions are 1. Does Tofacitinib significantly re...
Detailed Description
1.The researcher collects personal data, including age, gender, weight, height, body mass index, waist circumference, personal medical history, history of medication use in the past 3 months (menstrua...
Eligibility Criteria
Inclusion
- Thai males or females who were at least 18 years old
- Participants who were diagnosed with frontal fibrosing alopecia The criteria for the diagnosis of frontal fibrosis alopecia are 2 major criteria or 1 major criterion plus 2 minor criteria. (Vañó-Galván et al., 2014)
- Participants who were diagnosed with recalcitrant frontal fibrosing alopecia
- The patient who fails treatment of at least one drug, such as hydroxychloroquine, and/or receives others, such as immunosuppressive drugs, pioglitazone, and retinoids. However, the symptoms of FFA still appear, such as perifollicular erythematous and/or scale, after taking treatment for more than 3 months
- The patient continued taking the medicine as prescribed and coming to follow-up
- The patient still has the medical record, such as a picture and dermoscopy
- The patient does not need a washout time from the current medicine
Exclusion
- Patients who were diagnosed with a disease that may relate to hair growth within six months, such as thyroid disease, iron deficiency anemia, liver disease, heart disease, neurological system disease, gastroenteritis disease, sexual disease, cancer, and psychologic disease
- Pregnancy
- Patients who have contraindications to take oral Tofacitinib such as severe infection, allergy to Tofacitinib, venous thromboembolism, leukopenia, severe liver disease, severe kidney failure, pneumonia, cancer
- Patients who received strong or moderate to strong CYP3A4 agents
- Patients who had positive on HBsAg and/or HCV
Key Trial Info
Start Date :
November 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT06202560
Start Date
November 29 2023
End Date
July 10 2024
Last Update
May 30 2025
Active Locations (1)
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1
Hair and Nail center, Institute of Dermatology
Bangkok, Thailand, 10400